Data Quality Coordinator

Job Title:                                       Data Quality Coordinator                                      

Major Responsibilities:

• Review specification material needed to conduct clinical data management activities such as Data Management Plans, Data Transfer Agreements, Image Review Charters, etc.
• Perform quality review of test transfer outputs and verify compliance with project specification material prior to external delivery
• Develop quality control templates and support tools to verify the data in programmed outputs are accurate and formatted per sponsor specification requirements
• Participate in User Acceptance Testing (UAT) and data quality control review of data outputs generated in both automated and manual fashions to verify the integrity of the data generated
• Perform ongoing data reconciliation and facilitate tracking issues identified, triaging resolution requests to the responsible parties, and verifying resolution actions have been completed as appropriate throughout study conduct and close-out
• Review and cross-check deliverable outputs against project documentation and original data origins to ensure data are accurate and being delivered per the project requirements and sponsor specifications
• Collect, analyze, and report data to meet customer needs; report on trends in data and provide feedback as part of data quality review;
• Identify and report on trends from sources of raw data to increase the efficiency of the project
• Audit, quality control and spot check databases, ensuring quality of information processes are in place.
• Lead data management and analysis efforts.
• Write test scripts and evaluate results.
• Manage and track QA program for Technical QC
• Develop and maintain study eCRFs and databases, database edits, rules, and derivations utilizing varying software programs and reporting

Qualifications: 

• Education
  • Bachelor’s degree in Computer Science, Life Sciences or related field preferred, or equivalent experience required
• Experience
  • 2-4 years of experience in Clinical Data Management, Site Monitoring or related experience
  • Working knowledge of the clinical drug development process, FDA regulatory requirements, ICH, GCP and 21 CFR Part 11 guidelines, CDISC SDTM standards, and Data Management industry standard practices
  • Microsoft Excel proficiency required.
  • Experience performing user acceptance testing in a clinical data management setting
  • Attention to detail, as well as strong organizational, communication, and time management skills
  • Oncology and/or Neurology experience preferre
  • Proficient-Expert experience in Excel

What We Offer:

• Competitive salary
• Full Benefits 
• 401k with generous matching
• Flexible vacation policy

Successful candidates must comply with COVID-19 Workplace Safety mandate requirements

Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.